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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2010-D-0431]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” This guidance document describes FDA's current policies with respect to civil money penalties and no-tobacco-sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products, including the FD&C Act requirement that tobacco products may not be sold or distributed in violation of FDA's “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.” With the release of this final guidance document, several provisions in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders become effective.

# DATES:

Submit either electronic or written comments on Agency guidances at any time.

# ADDRESSES:

                        Submit written requests for single copies of the guidance entitled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers” to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the                         **SUPPLEMENTARY INFORMATION**                         section for electronic access to the guidance document.                    

                        Submit electronic comments on the guidance to                         *http://www.regulations.gov.*                         Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.                    

# FOR FURTHER INFORMATION CONTACT:

                        Gerie A. Voss, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373,                         *gerie.voss@fda.hhs.gov.*

# SUPPLEMENTARY INFORMATION:

## I. Background

FDA is announcing the availability of a guidance for FDA staff and tobacco retailers entitled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” On June 22, 2009, President Obama signed the Tobacco Control Act (Pub. L. 111-31) into law. The Tobacco Control Act grants FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

Among its many provisions, the Tobacco Control Act authorizes FDA to impose civil money penalties for violations of the FD&C Act requirements that relate to tobacco products (section 303(f)(9) of the FD&C Act (21 U.S.C. 333(f)(9)). Of special interest to retailers, one of the FD&C Act's requirements is that tobacco products may not be sold or distributed in a manner that violates regulations issued under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), such as the “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” that were published by FDA on March 19, 2010 (75 FR 13225) (21 CFR part 1140). The Tobacco Control Act also authorizes FDA to impose a no-tobacco-sale order on a retail outlet for repeated violations of regulations issued under section 906(d) of the FD&C Act, and discusses a number of technical and procedural issues relating to civil money penalties and no-tobacco-sale orders.

This guidance document describes the penalty structure and FDA policies with respect to civil money policies and no-tobacco-sale orders. With the release of this final guidance document, several Tobacco Control Act provisions that relate to civil money penalties and no-tobacco-sale orders become effective (section 103(q)(3) of the Tobacco Control Act).

                    In the                     **Federal Register**                     of August 31, 2010 (75 FR 53316), FDA announced the availability of the draft guidance of the same title dated August 2010. FDA received a few comments on the draft guidance, and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity.                

## II. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

## III. Comments

                    Interested persons may submit to the Division of Dockets Management (see                     **ADDRESSES**                    ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.                           ( print page 22906)                        Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.                

## IV. Electronic Access

                    Persons with access to the Internet may obtain the guidance at either                     *http://www.fda.gov/​TobaccoProducts/​GuidanceComplianceRegulatoryInformation/​default.htm*                     or                     *http://www.regulations.gov.*

                        Dated:                         *April 15, 2011.*

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2011-9938 Filed 4-22-11; 8:45 am]

BILLING CODE 4160-01-P